PCOS is the most common endocrine disturbance of women of reproductive age, affecting approximately 6-10% of women in this population, and is a common cause of infertility. PCOS has a similar incidence among ethnic and racial groups.
PCOS is characterized by traits that include but are not necessarily limited to abnormal accumulation of small follicles within the ovary, oligomenorrhea or amenorrhea, acne, Acanthosis nigricans, male pattern alopecia, increased ovarian androgen production, infertility/first trimester miscarriage, hirsutism, hyperinsulinemia/insulin resistance and obesity. Clinical criteria for PCOS include hyperandrogenemia, increased total testosterone and/or bioavailable testosterone, oligo-ovulation, polycystic ovaries and fewer than six periods/year. When attempting to definitively diagnose PCOS, other causes of these symptoms (e.g., tumors secreting androgens, congenital adrenal hyperplasia, Cushing's syndrome) need to be excluded.
Currently, diagnosis of PCOS is complex and frequently involves testing of hormone levels to rule out late-onset congenital adrenal hyperplasia (LOCAH) or non-classical adrenal hyperplasia (NCAH), and Cushing's syndrome. Testing frequently performed includes measurements of Testosterone, Dehydroepiandrosterone sulfate (DHEAS), 17α-Hydroxyprogesterone, Sex hormone-binding globulin (SHBG), prolactin levels, thyroid function tests, and transvaginal ultrasound to assess ovarian morphology. Thus, there remains a longstanding need for improved compositions and methods that can be used in connection with PCOS diagnosis, for monitoring therapeutic/surgical interventions, and for selecting patients for personalized therapeutic approaches. The present invention meets these and other needs.